AMAG Pharmaceuticals, Inc. Studies
Ciraparantag is in clinical development as a reversal agent for various anticoagulants including non-vitamin K oral anticoagulants (NOACs). Ciraparantag was previously shown to reverse the anticoagulant effects of edoxaban and enoxaparin, as measured by whole blood clotting time (WBCT).
Bioanalytical Drug Tolerance Limit Prediction and Optimization Model Developed Through Machine Learning With TensorFlow
Award winning poster presented at the 14th WRIB
“The selection is based on novelty of the concept, utility of the approach and the presentation style. It was a difficult decision for us to select 1 winner from total of 11 posters since the posters are generally with high quality and have addressed common challenges in the field with solid data. The winning poster stands out for its novelty, applying machine learning to predict drug tolerance of ADA method. Drug tolerance is a critical parameter for ADA method performance and is often the most resource-intensive component of ADA assay development. Although more data may be needed to further evaluate the prediction accuracy prior to broad implementation, the machine learning approach has the potential to streamline ADA method development and significantly improve the efficiency of immunogenicity assessment.”
Bioanalytical Large Molecule
Gain access to comprehensive biologics services in support of advanced development programs with Frontage’s bioanalytical laboratory. We have the capabilities to analyze virtually any peptide, protein or antibody, and have built a reputation for solving technical challenges related to assay development and validation.
CMC Product Development
Frontage’s CMC portfolio of services spans drug product development, analysis, delivery and supply, from proof-of-concept, preclinical stages through Phase III clinical trials and commercialization support. With proven success in developing drug products for novel, generic and consumer products, we focus our efforts on clients’ specific needs. Our formulation development experience and capabilities cover a wide range of dosage forms at IND, NDA, ANDA and 505(b)(2) project stages and applications.
Validating The Simoa Technology
Most of the advanced instruments used in bioanalysis—such as Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), and Liquid Chromatography-Mass Spectrometry (LC-MS) for example—are automated. Thus, they are controlled by complex computer systems, and the information they generate is stored electronically. If these systems are to be used in regulated research studies in the US, EU, and Japan, the instruments themselves must be qualified and their supporting software and processes must be validated as meeting regulatory requirements.
Bioanalytical Small Molecule
Frontage’s experienced staff and state-of-the-art instrumentation delivers data you can trust. Count on Frontage Laboratories for reliability. From method development or transfer and validation to sample analysis and reporting, Frontage’s bioanalytical team has earned a reputation for consistent and high-quality delivery, project after project. Our bioanalytical expertise extends to combined small and large molecules such as protein, antibody, antibody drug conjugates as well as biomarker analysis for small molecule drug candidates.